NCT05161195

Roll-over Study to Allow Continued Access to Ribociclib

A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).

Detailed description

This is an open-label, multi-center, roll-over study to evaluate the long-term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment. This roll-over study will not include a screening phase, participants will directly transfer at the completion of the parent study. Eligible participants will start receiving ribociclib in combination with other drugs (as per parent protocol) only after they have signed the Informed Consent and have met the selection criteria for this roll-over study. Participants should return to the study center for resupply of the study medication and for safety and clinical benefit assessment, at a minimum, every 24 weeks, or more frequently at any given time required as per local practice.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Ribociclib	Participants continue ribociclib as was administered in their parent study
DRUG	Letrozole	Participants continue ribociclib in combination with letrozole as was administered in their parent study
DRUG	Anastrozole	Participants continue ribociclib in combination with anastrozole as was administered in their parent study
DRUG	Goserelin	Participants continue ribociclib in combination with goserelin as was administered in their parent study
DRUG	Tamoxifen	Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
DRUG	Fulvestrant	All participants continue ribociclib in combination with fulvestrant as was administered in their parent study

Timeline

• Start date: 2022-07-07
• Primary completion: 2030-06-28
• Completion: 2030-08-14
• First posted: 2021-12-17
• Last updated: 2026-04-02

Locations

73 sites across 22 countries: United States, Argentina, Brazil, China, Costa Rica, Greece, Hong Kong, India, Italy, Japan, Lebanon, Mexico, Peru, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Vietnam

Regulatory

• FDA-regulated drug study